May 22, 2007
Avandia raises heart attack risk: NEJM analysis
GlaxoSmithKline’s Type-2 diabetes treatment Avandia (rosiglitazone) “significantly increases” the risk of heart attacks, according to an analysis of studies published yesterday on the Web site of The New England Journal of Medicine (NEJM).
The analysis, conducted by prominent Cleveland Clinic cardiologist Steven Nissen, also found that rosiglitazone increased the risk of death from cardiovascular causes that had “borderline significance.”
Overall, the analysis concluded that patients receiving rosiglitazone had a 43% increase in the risk of having a heart attack, compared to patients not receiving the drug--a “significant increase” Nissen said. The analyzed trials involved 15,560 patients who received drugs containing rosiglitazone and 12,283 who either received other drugs or a placebo.
GlaxoSmithKline said in a statement it strongly disagreed with the conclusions of the article which it said are based on incomplete evidence and a methodology that the author admits has significant limitations.
“GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks,” the drugmaker said.
GlaxoSmithKline added that longer term studies of the drug are currently under way.
The FDA said in a statement it has not yet confirmed the clinical significance of the reported increased risk in the studies and is not asking GlaxoSmithKline to take any specific action at this time.
Avandia was approved in 1999 for treatment of Type 2 diabetes, a disease that affects about 18 to 20 million Americans. Avandia had US sales of approximately $2.2 billion in 2006.